Efficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia: Retrospective Analysis of Real-Life Data

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dc.authoridYILMAZ, Mehmet/0000-0002-5710-5263
dc.authoridBasturk, Abdulkadir/0000-0003-1864-0316
dc.authoridDemircioğlu, Sinan/0000-0003-1277-5105
dc.authoridDogu, Mehmet Hilmi/0000-0001-7237-2637
dc.authoridDurusoy, Salih Sertaç/0000-0002-3577-6330
dc.authoridokan, vahap/0000-0002-9869-8181
dc.authoridCekdemir, Demet/0000-0002-1881-5166
dc.authorwosidYILMAZ, Mehmet/HKM-4739-2023
dc.authorwosidBasturk, Abdulkadir/B-1962-2018
dc.authorwosidDemircioğlu, Sinan/AAF-9901-2020
dc.authorwosidDogu, Mehmet Hilmi/W-2255-2017
dc.authorwosidDurusoy, Salih Sertaç/HTL-5545-2023
dc.authorwosidÜnal, Ali/F-9276-2013
dc.authorwosidGURKAN, EMEL/E-8808-2018
dc.contributor.authorTombak, Anil
dc.contributor.authorTanrikulu, Funda Pepedil
dc.contributor.authorDurusoy, Salih Sertac
dc.contributor.authorDincyurek, Huseyin Derya
dc.contributor.authorKaya, Emin
dc.contributor.authorUmit, Elif Gulsum
dc.contributor.authorYavasoglu, Irfan
dc.date.accessioned2024-08-04T20:10:09Z
dc.date.available2024-08-04T20:10:09Z
dc.date.issued2021
dc.departmentİnönü Üniversitesien_US
dc.description.abstractObjective: This study aimed to retrospectively evaluate the efficacy, safety, and survival outcome of single-agent ibrutinib therapy in chronic lymphocytic leukemia patients. Materials and Methods: A total of 136 patients (mean age +/- standard deviation: 64.6 +/- 10.3 years, 66.9% males) who had received at least one dose of ibrutinib were included in this retrospective multicenter, noninterventional hospital-registry study conducted at 33 centers across Turkey. Data on patient demographics, baseline characteristics, laboratory findings, and leukemia-cell cytogenetics were retrieved. Treatment response, survival outcome including overall survival (OS) and progression-free survival (PFS), and safety data were analyzed. Results: Overall, 36.7% of patients were categorized as Eastern Cooperative Oncology Group (ECOG) class 2-3, while 44.9% were in Rai stage 4. Fluorescence in situ hybridization revealed the presence of del(17p) in 39.8% of the patients. Patients received a median of 2.0 (range: 0-7) lines of pre-ibrutinib therapy. Median duration of therapy was 8.8 months (range: 0.4-58.0 months). The 1-year PFS and OS rates were 82.2% and 84.6%, respectively, while median PFS time was 30.0 (standard error, 95% confidence interval: 5.1, 20.0-40.0) months and median OS time was 37.9 (3.2, 31.5-44.2) months. Treatment response (complete or partial response), PFS time, and OS time were better with 0-2 lines versus 3-7 lines of prior therapy (p<0.001, p=0.001, and p<0.001, respectively), with ECOG class 0-1 versus class 2-3 (p=0.006, p=0.011, and p=0.001, respectively), and with Rai stage 0-2 versus 3-4 (p=0.002, p=0.001, and p=0.002, respectively). No significant difference was noted in treatment response rates or survival outcome with respect to the presence of comorbidity, bulky disease, or del(17p). While 176 adverse events (AEs) were reported in 74 (54.4%) patients, 46 of those 176 AEs were grade 3-4, including pneumonia (n=12), neutropenia (n=11), anemia (n=5), thrombocytopenia (n=5), and fever (n=5). Conclusion: This real-life analysis confirms the favorable efficacy and safety profile of long-term ibrutinib treatment while emphasizing the potential adverse impacts of poorer ECOG performance status, heavy treatment prior to ibrutinib, and advanced Rai stage on patient compliance, treatment response, and survival outcomes.en_US
dc.description.sponsorshipJanssen Pharmaceutica Turkeyen_US
dc.description.sponsorshipThis study was supported by Janssen Pharmaceutica Turkey. The authors would like to thank Prof. Sule Oktay, MD, PhD, and Cala Ayhan, MD, from KAPPA Consultancy Training Research Ltd. (stanbul, Turkey) , who provided editorial support.en_US
dc.identifier.doi10.4274/tjh.galenos.2021.2021.0007
dc.identifier.endpage285en_US
dc.identifier.issn1300-7777
dc.identifier.issn1308-5263
dc.identifier.issue4en_US
dc.identifier.pmid34448556en_US
dc.identifier.scopus2-s2.0-85122065652en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage273en_US
dc.identifier.trdizinid508839en_US
dc.identifier.urihttps://doi.org/10.4274/tjh.galenos.2021.2021.0007
dc.identifier.urihttps://search.trdizin.gov.tr/yayin/detay/508839
dc.identifier.urihttps://hdl.handle.net/11616/92619
dc.identifier.volume38en_US
dc.identifier.wosWOS:000730491500003en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakTR-Dizinen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherGalenos Yayinciliken_US
dc.relation.ispartofTurkish Journal of Hematologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectChronic lymphocytic leukemiaen_US
dc.subjectIbrutiniben_US
dc.subjectBruton's tyrosine kinase inhibitoren_US
dc.titleEfficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia: Retrospective Analysis of Real-Life Dataen_US
dc.typeArticleen_US

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